Influence of Corticoids on Renal Function in Cardiac Surgery

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Elective Cardiac Surgery

Treatments: Drug: Placebo; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00879931

2006/031

Details and patient eligibility

About

Hypothesis: Corticoid treatment in cardiac surgery works renal protective.

Study design: Randomized, double blind trial in which one group of patients will receive methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.

Enrollment: 80 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 20-80 year
• patients scheduled for elective cardiac surgery.
• preoperative creatinine levels of < 2mg/dl
• no corticoid treatment

Exclusion criteria

• non-elective surgery
• patiënts with renal dysfunction: creatinine > 2mg/dl
• patiënts treated with corticoids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

methylprednisolone

Treatment:

Drug: Methylprednisolone

2

Placebo Comparator group

Description:

Placebo (NaCl 0.9%)

Treatment:

Drug: Placebo